CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment (X:BOT)

John Rotrosen, MD
Lead Investigator

New York University School of Medicine

This study will assess the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®) versus buprenorphine-naloxone (BUP-NX, Suboxone®) as pharmacotherapeutic aids to recovery amongst treatment-seeking participants who have completed detoxification and achieved short term abstinence. The primary objective is to compare the effectiveness of XR-NTX versus BUP-NX in promoting the joint outcome of sustained retention in treatment and abstinence after an index admission for opioid dependence. A rescue protocol will enable the study to address additional questions regarding the sequencing of treatments.

Primary Findings

Participants randomized to XR-NTX had a substantial induction hurdle: fewer successfully initiated XR-NTX than BUP-NX, resulting in a higher rate of 24-week relapse events for the XR-NTX group. Among participants successfully inducted to treatment, however, 24-week relapse events were similar across study groups. Self-reported opioid craving was initially less with XR-NTX than with BUP-NX (p=0.0012), then converged by week 24 (p=0.20). With the exception of mild-to-moderate XR-NTX injection site reactions, treatment-emergent adverse events including overdose did not differ between treatment groups.

In this population, it is more difficult to initiate patients to XR-NTX than to BUP-NX, and this negatively affected overall relapse. However, once initiated, both medications were equally safe and effective.

Primary Outcomes Article: Lee JD, et al. Comparative Effectiveness of Extended-Release Naltrexone Versus Buprenorphine-Naloxone for Opioid Relapse Prevention (X:BOT): A Multicentre, Open-Label, Randomised Controlled Trial. The Lancet 2018;391(10118):309-318. [get article]

    Node Involvement

    Lead Node(s):

  • New England Consortium Node
  • New York Node

  • All Participating Nodes:

  • Florida Node Alliance
  • Mid-Atlantic Node
  • New England Consortium Node
  • New York Node
  • Ohio Valley Node
  • Pacific Northwest Node
  • Pacific Region Node